Improving Syncope Risk Stratification in Older Adults
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 60 - Any |
Updated: | 1/26/2019 |
Start Date: | April 2013 |
End Date: | December 14, 2016 |
Syncope (temporary loss of consciousness) is a frequent reason for an emergency department
(ED) visit among older adults. The current ED evaluation of syncope frequently leads to
hospitalization, results in low diagnostic yield, and is enormously costly. The purpose of
this protocol is to improve risk prediction for syncope. Improved risk prediction will inform
the design of interventions to safely reduce unnecessary health service use.
This is a multi-center, prospective, observational cohort study of older (age≥60 years)
adults who present to an emergency department with syncope (otherwise known as fainting). The
primary outcome is a composite of 30-day cardiac death and serious cardiac events.
Study Aims and Hypotheses are:
Specific Aim 1. Describe serious outcomes after unexplained syncope; rates and reasons for
admission; and frequency, diagnostic yield, and therapeutic impact of inpatient diagnostic
tests.
H1: Current patterns of care representing a diversity of practice settings and patient
populations are costly with low clinical benefit.
Specific Aim 2. Derive and validate a novel risk prediction model for 30-day cardiac death
and serious cardiac outcomes after unexplained syncope.
H2: Explicit criteria including contemporary cardiac biomarkers will improve risk
stratification compared to unstructured physician assessment and published risk models.
Specific Aim 3. Assess safety and costs of a risk-tailored diagnostic algorithm compared to
existing care for unexplained syncope.
H3: A risk-tailored diagnostic algorithm can safely reduce the costs of evaluating
unexplained syncope in older adults.
(ED) visit among older adults. The current ED evaluation of syncope frequently leads to
hospitalization, results in low diagnostic yield, and is enormously costly. The purpose of
this protocol is to improve risk prediction for syncope. Improved risk prediction will inform
the design of interventions to safely reduce unnecessary health service use.
This is a multi-center, prospective, observational cohort study of older (age≥60 years)
adults who present to an emergency department with syncope (otherwise known as fainting). The
primary outcome is a composite of 30-day cardiac death and serious cardiac events.
Study Aims and Hypotheses are:
Specific Aim 1. Describe serious outcomes after unexplained syncope; rates and reasons for
admission; and frequency, diagnostic yield, and therapeutic impact of inpatient diagnostic
tests.
H1: Current patterns of care representing a diversity of practice settings and patient
populations are costly with low clinical benefit.
Specific Aim 2. Derive and validate a novel risk prediction model for 30-day cardiac death
and serious cardiac outcomes after unexplained syncope.
H2: Explicit criteria including contemporary cardiac biomarkers will improve risk
stratification compared to unstructured physician assessment and published risk models.
Specific Aim 3. Assess safety and costs of a risk-tailored diagnostic algorithm compared to
existing care for unexplained syncope.
H3: A risk-tailored diagnostic algorithm can safely reduce the costs of evaluating
unexplained syncope in older adults.
Inclusion Criteria:
1. age≥60 years; AND
2. a complaint of syncope or near-syncope. Syncope is defined as a transient loss of
consciousness (LOC), associated with loss of postural tone, with immediate,
spontaneous, and complete recovery. Near-syncope is the sensation of imminent syncope
without loss of consciousness.
Exclusion Criteria:
- Seizure as presumptive cause of LOC
- Stroke or transient ischemic attack as presumptive cause of LOC
- LOC AFTER head trauma Confusion from baseline mental status
- Intoxicated (alcohol or other drugs)
- Medical or electrical intervention to restore consciousness
- Hypoglycemia as presumptive cause of LOC
- inability to provide follow-up information, including patients who do not speak
English (or Spanish, if applicable for study site), lack phone access, or lack a
permanent address
- Inability or unwillingness of individual or legal guardian/representative to give
written informed consent
We found this trial at
10
sites
Winston-Salem, North Carolina 27157
Principal Investigator: Bret Nicks, MD
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75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Christopher W Baugh, M.D.,M.B.A.
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Alan B Storrow, MD
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Principal Investigator: Benjamin C Sun, MD
Phone: 503-494-1193
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Akron, Ohio 44304
Principal Investigator: Scott Wilber, MD
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281 W. Lane Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Jeffrey Caterino, MD
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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1020 Walnut St
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Judd Hollander, MD
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Sacramento, California 95817
Principal Investigator: Daniel Nishijima, MD
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